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Optical Frequency Domain Imaging (OFDI) Surveillance and Image Guided Biopsy of the Esophagus

This study has been completed.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Guillermo Tearney, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01439633
First received: September 20, 2011
Last updated: July 25, 2014
Last verified: July 2014

September 20, 2011
July 25, 2014
October 2010
May 2014   (final data collection date for primary outcome measure)
Feasibility and specificity of OFDI marking and imaging [ Time Frame: Images will be acquired during the OFDI imaging session which should take an average of 5 mintues ] [ Designated as safety issue: No ]
Determination of the feasibility to mark targeted pathologic locations identified through OFDI imaging using superficial cautery marks.Verification by endoscopy and utilization of the marks for biopsy guidance.Images will be analyzed and compared to biopsies of the correlated marked tissue.
Same as current
Complete list of historical versions of study NCT01439633 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Optical Frequency Domain Imaging (OFDI) Surveillance and Image Guided Biopsy of the Esophagus
Pilot Study to Evaluate OFDI Surveillance and Image Guided Biopsy of the Esophagus

The specific aim of this study is to determine the feasibility of marking target pathologic locations identified on Optical Frequency Domain Imaging (OFDI) datasets using superficial cautery marks of the esophagus that are visible by endoscopy for subsequent guidance of biopsy.

Twenty four consenting patients undergoing esophagogastroduodenoscopy (EGD) surveillance following a confirmed diagnosis of Barrett's esophagus will be recruited at Massachusetts General Hospital (MGH) . Along with Optical Frequency Domain Imaging (OFDI) imaging and cautery marking for targeted biopsy, the patients will undergo a standard of care clinical Esophagogastroduodenoscopy (EGD) procedure including endoscopic random biopsy. This study requires the use of a balloon catheter which is a commonly used technique and is accepted in clinical practice for dilation of esophageal and colonic strictures and for photodynamic therapy.

Once in position, the OFDI tissue marking laser will be activated by the physician. The physician will control the marking and make two marks of a duration of 2 seconds each. The 2 seconds time period will limit the tissue effects to only the superficial layers of the esophageal mucosa.

It is expected that the total experimental time including insertion and inflation of the OFDI balloon catheter, OFDI imaging, tissue marking, and removal of the OFDI balloon will add approximately 15 minutes to the total length of the EGD.

Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Barrett's Esophagus
Device: MGH Optical Frequency Domain Imaging (OFDI) system
Imaging of esophagus with OFDI system
Experimental: OFDI imaging
OFDI imaging
Intervention: Device: MGH Optical Frequency Domain Imaging (OFDI) system
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
May 2014
May 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients undergoing an EGD for Barrett's esophagus surveillance with a prior confirmed Barrett's segment at least 1 cm in length
  • Patients must be over the age of 18
  • Patient must be able to give informed consent
  • Women with child bearing potential must have a negative pregnancy test prior to procedure

Exclusion Criteria:

  • Patients on anti-platelet and anti-coagulation medications and NSAIDS at the time of procedure
  • Patients with a history of hemostasis disorders
  • Patients that are pregnant
  • Patients with esophageal strictures
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01439633
2010-P-000553, 2R01CA103769-06A1
No
Guillermo Tearney, Massachusetts General Hospital
Massachusetts General Hospital
  • National Institutes of Health (NIH)
  • National Cancer Institute (NCI)
Principal Investigator: Guillermo Tearney, MD PhD Massachusetts General Hospital
Principal Investigator: Norman Nishioka, MD Massachusetts General Hospital
Massachusetts General Hospital
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP